EXPRESSION OF CONCERN: Consensus on ventral rectopexy: report of a panel of experts

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Abstract

Ventral rectopexy (VR) has gained in popularity amongst colorectal surgeons as an operation that addresses functional bowel symptoms by correcting anatomical abnormalities in patients with internal (rectal intussusception) and external rectal prolapse. The operation includes fixation of a synthetic or biological implant to the ventral rectum and vaginal vault. There is current concern over the fixation of any material placed transvaginally or paravaginally in pelvic organ prolapse surgery because of the risks of erosion and sepsis 1. Concerns have also been expressed regarding patient selection for VR, choice of material, operative technique and a lack of high-level evidence. In order to address these concerns, two Consensus Conferences were held, the first on 25 September 2012 at the Austria Trend Hotel, Vienna, Austria and the second on 17 May 2013 at St John's College, Oxford, UK to develop a consensus opinion from expert colorectal surgeons with a subspeciality of pelvic floor practice and experience of performing VR. Most had performed 100 or more ventral rectopexies. The goal of pelvic organ prolapse surgery is to restore anatomy and improve function and quality of life. Despite its shortcomings, the PROSPER trial conducted by the Association of Coloproctology of Great Britain and Ireland (ACPGBI), which compared surgical treatments for external rectal prolapse, showed high recurrence rates for perineal and posterior abdominal rectal approaches 2, but it did show improved quality of life. VR emerged as a new, autonomic nerve-sparing operation for external rectal prolapse 3. Anterior mobilization had been described in the early 1980s 4, but VR was new because it avoided a posterior rectal mobilization. Posterior mobilization was shown in randomized studies 5, 6 to be associated with rectal inertia, and a Cochrane Review of external prolapse concluded that it was associated with more postoperative constipation 7. A systematic review comparing ventral and posterior rectal mobilization also concluded that the former was associated with less constipation 8. Unlike posterior rectopexy, VR had the potential to correct any coexisting middle compartment prolapse. Five-year recurrence rates of less than 5% and improvements in faecal incontinence are acceptable 3, and similar to those established for posterior rectopexy 9. Laparoscopic surgery has made the application of these techniques safer than with open surgery. Laparoscopic posterior rectopexy was established well before laparoscopic VR, but because the dissection was no different from posterior rectopexy, the functional problems remained 8. It was the improvement in constipation in most patients following VR which attracted the attention of surgeons 3. In the 1980s and 1990s, poor function after posterior rectopexy 10 and a belief that internal rectal prolapse was a variant of normal 11 seldom leading to external rectal prolapse 12 resulted in a 'medicalization' of treatment and a reduction of surgery. With a better understanding of internal rectal prolapse as a morphologically distinct finding in patients with evacuation disorder 13 combined with improved defaecation after VR for external prolapse, led to its adoption for internal rectal prolapse 14. Medium-term results were reported for patients with mechanical outlet obstruction and external or internal rectal prolapse 15. At a median follow-up of 54 months, there was no recurrence of external prolapse and a more than 80% improvement in constipation and incontinence scores. Collinson et al. 16 and others 17, 18 reported similar excellent short-term functional results for patients with internal rectal prolapse. Recent publications have shown improvements in quality of life and sexual function after VR 17, 19, 20, although an earlier study had reported little improvement following VR for symptomatic rectocele 21. All series demonstrated VR to be safe with no mortality and an acceptably minimal morbidity. Despite the increasing popularity of this procedure there is only Level 3 evidence to support its use, with one systematic review showing a greater reduction in postoperative constipation if VR is used without posterior rectal mobilization for internal and external rectal prolapse 8. In 2011 the US Food and Drug Administration (FDA) published an updated document on the safety of transvaginally placed mesh for pelvic organ prolapse. The conclusion was that there was serious concern regarding safety and effectiveness 1. Synthetic mesh or biological implant fixation during VR is more analogous to sacrocolpopexy (paravaginal) than transvaginal fixation. A systematic review of surgery for vaginal vault and uterine prolapse included 54 studies and over 7000 patients 22. The authors reported a synthetic mesh erosion rate of 0–12% but this was 0% for biological implants in relevant studies. A subsequent study of laparoscopic sacrocolpopexy comparing biological implants with polypropylene mesh showed erosion rates of 5% for biological mesh compared with 9% for synthetic mesh 23. The following recommendations arose from the consensus meetings with agreement by the panel. The term ventral rectopexy (VR) was chosen 3. The procedure can be open or performed laparoscopically or robotically with synthetic mesh or biological implant. Patients with external rectal prolapse who are deemed fit for general anaesthesia. Age should not be a precluding factor 24. Both sexes should be considered suitable, as should adolescents, a rare circumstance. Patients with symptomatic high-grade (Oxford Grades 3 or 4) internal rectal prolapse who have failed to respond to conservative therapy may be candidates for VR. It was recognized that symptoms may include obstructed defaecation and/or faecal incontinence. The consensus panel agreed that VR could be performed for complex rectocele of more than 3–4 cm, usually accompanied by high-grade internal rectal prolapse and an enterocele 20, 25. Such patients should have symptoms that are having a significant impact on their quality of life and should have failed maximal conservative therapies or have failed to respond to simple perineal procedures. Solitary rectal ulcer syndrome associated with internal rectal prolapse was also considered as a possible relative indication for VR 19. Men presenting with symptomatic internal rectal prolapse are uncommon. The consensus panel felt that surgery for this group was more difficult and had greater potential risks. Morbid obesity (BMI > 40 kg/m2) makes pelvic dissection difficult and there may be an increased risk of recurrence after surgery. Other relative contraindications include high-grade endometriosis, previous pelvic radiotherapy and previous sigmoid peridiverticulitis. Surgeons should be wary of operating on patients with minimal bowel dysfunction, even if a high-grade internal rectal prolapse is evident. The severity of symptoms and their impact on quality of life should be important factors in deciding on surgery. The panel agreed that recurrence after VR may be greater in patients with benign joint hypermobility syndrome 26, obesity and those with excessive perineal descent associated with chronic straining. The panel also agreed that revisional surgery in patients with recurrence should be performed in specialized centres after full reassessment. History taking should focus on symptoms of obstructed defaecation, faecal and urinary incontinence and sexual function. Past medical history should ascertain whether previous pelvic prolapse procedures have been performed and especially if synthetic mesh was used. The psychological history should be considered. Assessment of the severity of symptoms should be made using validated subjective and objective scoring systems applied before and after surgery. These include the PAQ SYM, PAC QOL, ODS score, FISI score, Wexner score, Vaizey score and GIQL general QoL. This will allow changes of symptoms following the procedure to be quantified. It will also facilitate comparison of results between units. Clinical assessment of the anorectum and vagina should be performed with or without examination under anaesthesia, which may diagnose high-grade internal rectal prolapse. Investigations should exclude other pathology such as gynaecological by transvaginal/pelvic ultrasound and colorectal by colonoscopy and cross-sectional imaging where deemed necessary. Dynamic fluoroscopic defaecography with vaginal contrast (small bowel and bladder contrast optional) or MRI proctography should be performed. Urodynamics should be performed in patients with urinary symptoms or when vaginal vault prolapse is coexistent. Endoanal ultrasound and anorectal physiology studies should be performed as deemed clinically necessary. Perineal ultrasound when available is an alternative to endoanal ultrasound. Ideally management should be discussed at a pelvic floor multidisciplinary meeting, particularly for patients with internal rectal prolapse and those with mixed urological and colorectal symptoms. It is recognized that this may not be available in many units but it is likely that their number will increase in the future. It is possible to perform VR as a day case procedure within an enhanced recovery after surgery (ERAS) programme 27. This must include a discussion on the risks of conversion if performed laparoscopically or robotically, erosion or infection of the mesh or implant, potential damage to adjacent structures, recurrence and of port site hernia. Postoperative management and recovery should be discussed. Pregnancy test should be negative. A phosphate enema or similar be given to clear the rectum. Broad-spectrum antibiotics and subcutaneous low-dose heparin should be administered. The panel recommended a minimally invasive approach, either laparoscopically or robotically. A 30° camera facilitates the procedure. A Cochrane Review concluded that laparoscopic rectopexy was safer and associated with less pain and faster convalescence than open surgery 7. There was evidence that robotic VR was as safe as open surgery 28 and bowel function may possibly be better 29, although the number of cases and experience of robotic VR was limited. The ports are placed according to the surgeon's preference. Avoid 12-mm ports to minimize future port site herniation. Uterine: The uterus can be retracted superiorly by suture through the body and abdominal wall or through the broad ligaments. Occasionally a vaginal retractor will provide sufficient retraction. Sigmoid: The sigmoid can be retracted from the pelvis into the left iliac fossa by either (i) a surgical clip, tack or suture to secure to the abdominal wall or (ii) by placing an additional 5 mm port in the left iliac fossa and using an Endoloop onto an appendix epiploicae or (iii) using a T-Lift device (careful postprocedure inspection?). Vaginal: A vaginal Spackman cannula can be used or a transvaginal long plate retractor pushed into the posterior vaginal fornix. This retraction together with the use of rectal sizers can facilitate dissection of the recto-vaginal septum (and identification of the rectum in difficult cases). Diathermy or ultrasonic dissection is commenced at the sacral promontory. At this level care should be taken to avoid damage to the left hypogastric nerve and left iliac vein. Both left and right hypogastric nerves should be avoided during proximal mesh/implant fixation. Dissection progresses distally to the right side of the mesorectum, avoiding the right iliac vessels and ureter to the pouch of Douglas. Using vaginal retraction, the peritoneum at the superior part of the pouch is incised and a plane developed in the rectovaginal septum to the pelvic floor (upper external anal sphincter and puborectalis). The distal limit of dissection is confirmed by digital anal examination. In men, ventral dissection in the recto-vesical pouch to the apex of the prostate should be limited and lateral dissection around the seminal vesicles avoided. Any excess tissue of the pouch of Douglas is then resected or plicated when closing the peritoneum. A synthetic mesh or biological implant is measured and cut to size. Typically this is 18–20 cm long and 4 cm wide. This is placed on the ventral aspect of the rectum and sutured into place. Approximately six interrupted muscle sutures are placed on each side avoiding full-thickness insertion. More sutures might be considered in a patient with a connective tissue disorder such as Ehlers–Danlos syndrome, although data are lacking. Further sutures then are placed on the intraperitoneal rectum on the left side. This is important since it fixes a 'high take off' internal prolapse. Some surgeons secure the mesh or implant to the puborectalis 20. Long-term absorbable sutures, e.g. 2-O PDS (times two or three) should be used to secure the posterior fornix and pericervical fascia to the prosthesis to prevent enterocele formation. The panel expressed concern over the use of nonabsorbable sutures when securing synthetic mesh to the rectum because of the risk of erosion and it was suggested that absorbable sutures should be used such as 2-O PDS. The mesh or implant is secured to the longitudinal ligament over the sacral promontory using sutures, tacks or a screw. The disc and right hypogastric nerve should be avoided 30. Tension on the implant is difficult to judge but should be 'adequate', counterbalancing the pressure of the pneumoperitoneum and fixing the rectum in its natural/anatomical situation in the pelvis. It was agreed that apposition of the uterosacral ligaments (where present) and suturing of the pelvic peritoneum is essential to avoid adhesion/obstruction and reduce the risk of recurrence and/or symptomatic enterocele. Furthermore, it is important for biological implants to be covered to enhance tissue in-growth. The following are recommended. The urinary catheter can be removed at the end of the procedure. Intraperitoneal marcain (60 ml 0.25%) or transversus abdominis plane (TAP) block can be considered and is highly suitable for fast-track recovery. No dietary restrictions. Laxatives are recommended for 4–6 weeks, avoid constipating analgesics, aim for correct stool consistency (Type 4, Bristol stool chart). No heavy lifting for 4–6 weeks. Women may resume sexual activity when comfortable. Topical oestrogens can be used in postmenopausal women possibly to reduce the risk of mesh erosion. The prosthesis can be either a biological implant or a synthetic mesh. Only short-term evidence exists for the safety and efficacy of biologicals used in VR 17, 18. Biologicals can be either noncross-linked or cross-linked.. An example of a noncross-linked biological is Biodesign® (Cook Medical, Bloomington, Indiana, USA), and a cross-linked biological is Permacol® (Covidien, Gosport, UK). There is limited evidence that during paravaginal repair of pelvic organ prolapse cross-linked biologicals are more prone to cause erosion than with noncross-linked ones 31, 32. When using a biological implant the surgeon should consider the balance of cost, failure/recurrence and revisional surgery required, with low rates of prosthesis-related complications and good results from revisional surgery. The panel agreed that biological implants should be considered in the following circumstances: The group made the following recommendations concerning synthetic mesh: Titanium-coated light-weight polypropylene is the preferred option for VR. Polypropylene/monocryl is liable to stretch and result in recurrent symptoms. Heavier weight polypropylene shrinks considerably. Polyester has been associated with erosion problems and the group believes is contraindicated for use in VR. Complications whether following open or minimally invasive LV include the following: Synthetic mesh erosion rates are 2–3% after VR and may occur into the vagina (more commonly) or the rectum years after the procedure. Erosion may present with vaginal discharge or rectal symptoms. Biological implants have a different complication profile and revisional surgery is less demanding. Reoperation appears to be required less often for erosion when a biological rather than a synthetic mesh is used 23. There are, however, no long-term data available for VR. There is concern that a biological implant may be less durable in the intermediate term. Where revisional surgery for a complication is needed, the patient should be referred to a tertiary centre 33. The panel agreed that prospective data collection is recommended, and that long-term follow-up should include the completion of relevant subjective questionnaires. VR appears to be a safe and effective alternative for the fixation of external rectal prolapse and this is supported by limited long-term data. The outcome of VR in internal prolapse appears to be as good, but only short-term data exist. A lack of high-level evidence precludes definitive conclusions and prospective randomized trials are recommended. Patients undergoing VR should be entered into a prospective database so that mesh- and implant-related complications are recorded. The Panel reported that there is a considerable learning curve with VR, perhaps equivalent to 50 procedures, and that consultant mentoring should be provided. They recognized the importance of surgical fellowships and cadaveric or animal laboratories and workshops. They recommended that surgeons commence their VR practice by selecting fit patients with external prolapse. It was unanimously agreed that VR should be undertaken only by a trained colorectal surgeon with an interest in pelvic floor surgery and access to the recommended investigations. Participation and discussion about patients in multidisciplinary pelvic floor meetings should be encouraged. The meetings were supported by Cook Medical Incorporated (Bloomington, Indiana, USA). MMJ, AD'H, PL and ARLS received reimbursement for their expenses. ARLS is a VR preceptor for Cook Medical. MMJ is a VR preceptor for Covidien. The authors thank Cook Medical for their support for the consensus meetings and Professor Nicholls for his invaluable chairmanship of the meetings.

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